Oreana neonatal screening is a new genetic test for screening newborns, infants or children for treatable or manageable conditions. The disorders screened by Oreana have symptoms that may not be apparent at birth. However, symptoms for these conditions can manifest quickly, pose a critical threat to the health or future development of the infant and require urgent treatment.

With Oreana, early detection of life-altering conditions that could have a simple yet meaningful clinical management is possible, and allows for early, pro-active interventions that will benefit the infant’s health and quality of life.

WHAT DOES Oreana NEONATAL SCREENING TEST FOR?

Oreana screens for 106 genetic conditions that meet several of the following criteria:

Can be identified early, before the onset of detrimental, often irreversible symptoms

Can cause affected infants to degenerate very quickly without appropriate management

Are treatable, or could be manageable via tailored diet, supplements or medications

Have high incidence in the population

Have moderate to severe clinical phenotype, with variable expression of clinical symptoms

Early interventions could halt the onset of symptoms or limit their effect

Prompt identification and timely treatmentm of affected infants could prevent or minimize serious, life-long consequences such as:

  • Developmental delay
  • Cognitive impairment
  • Physical disability
  • Mental delay
  • Liver disease
  • Blindness
  • Neurological degeneration
  • Malnutrition
  • Premature death

Oreana includes Autosomal Recessive, Autosomal Dominant and X-Linked genetic conditions of metabolic, endocrine and haemoglobin nature, as well as hearing loss disorders, among others. For a complete list of the 106 diseases and 142 genes tested by Oreana, please visit www.nipd.com/oreanapanel.

Oreana tests for most conditions included in the 'Recommended Uniform Screening Panel' which is a list of disorders selected based upon the American College of Medical Genetics (ACMG) recommendations for newborn screening. Additional disorders were added to Oreana that were either part of the differential diagnosis or met the criteria listed above.

A MANAGEABLE CONDITION IS IDENTIFIED IN ABOUT 1 in 300 NEWBORNS*

Oreana neonatal screening can identify infants who are affected by a manageable or treatable disease soon after birth, before the onset of symptoms. The disorders tested could have detrimental effects on normal development, even lead to death. Most of these diseases have a vast array of symptoms once they manifest, making diagnosis lengthy and complicated. With timely detection, Oreana gives you the opportunity to take informed and early decisions on the best clinical management for your patient.

Oreana can also be used to identify genetic diseases in newborns, infants or children who present with a variety of clinical symptoms.

*Data collected from Centers for Disease Control and Prevention (2012); CDC Grand Rounds: Newborn screening and improved outcomes, and is based on screening of 29 diseases included in the core conditions of the Recommended Uniform Screening Panel.

WHO IS Oreana NEONATAL SCREENING FOR?

Asymptomatic newborns and infants for early detection

Newborns, infants or young children presenting with a clinical phenotype, for identification of the disease-causing variant

Oreana can benefit all newborns and infants, irrespective of their family’s genetic history. The conditions tested by Oreana may be inherited from carrier parents who are unaware of their genetic status to their children, they may have a hereditary component or no previous disease manifestation in the family history. Oreana neonatal screening can help in identifying and treating the affected child early, but also with providing the family with useful information on their genetic background and future family planning.

WHY CHOOSE Oreana NEONATAL SCREENING?

  • Results are reported quickly, to accommodate for timely and effective interventions
  • Complements national newborn screening programs
  • Testing for clinically actionable and highly penetrant mutations
  • Superior targeted genomic analysis, targeting all coding sequences of the tested genes
  • Expandable panel of disorders
  • High precision and accuracy
  • High sensitivity and specificity
  • Non-invasive, painless and safe for the infant

WHY RECOMMEND Oreana IN ADDITION TO NEONATAL SCREENING?

National newborn screening programs offer great advantages for infants, their families and national health systems. However, because they are subjected to each country's regulations, healthcare system and available funds, implementation of changes, such as use of more advanced technology or addition of clinically important diseases, can take time. As a result, the number of conditions tested is vastly different throughout Europe and the world; some countries perform newborn screening ranging from only 2 disorders to over 35.

With Oreana neonatal screening, 106 conditions that are treatable or manageable can be detected before appearance of clinical signs in asymptomatic newborns. With early interventions, irreversible damages to the infant can be limited or prevented, benefiting their quality of life. Additionally, accurate identification of disease-causing variants in symptomatic newborns can signify the start of beneficial, therapeutic treatment.

* Data collected from Centers for Disease Control and Prevention (2012); CDC Grand Rounds: Newborn screening and improved outcomes, and is based on screening of 29 diseases included in the core conditions of the Recommended Uniform Screening Panel.

WHAT ARE THE BENEFITS OF EARLY DETECTION?

  • Prevent the onset of symptoms
  • Minimize the severity of symptoms
  • Limit irreparable health damage
  • Avoid a late and lengthy diagnosis
  • Start early interventions and clinical management
  • Advice on available experimental therapies or clinical trials, where appropriate

TECHNOLOGICAL ADVANTAGES

Oreana uses a targeted genomic analysis and a robust, validated multiengine analysis platform to screen for clinically actionable, highly penetrant gene mutations with high sensitivity and specificity.

TARGETED TECHNOLOGY

Oreana neonatal screening is based on a novel, target capture enrichment technology that has been thoroughly validated for its accuracy and precision.

FULL COVERAGE

Oreana screens for all coding regions on the genes tested, examining single nucleotide variants, small insertions and deletions and copy number variants.

NOVEL BIOINFORMATICS

Innovative bioinformatics pipelines analyze the sequencing data produced from each sample, increasing the sensitivity and specificity of Oreana neonatal screening.

WHEN IS THE OPTIMAL TIME TO PERFORM Oreana?

Oreana neonatal screening can be performed anytime after the first 24 hours of birth, up to early childhood. For many of the disorders tested by Oreana, the age of diagnosis can determine the prognosis and severity of symptoms. Since the introduction of newborn screening programs, earlier detection and starting treatment as soon as possible have improved the life expectancy and quality of life of affected infants.

WHAT WILL THE REPORT TELL ME?

Positive or negative results on mutations detected

Thorough interpretation and significance of any positive mutations detected

Variants of Unknown Significance (VUS) are not reported. Inconclusive results may occasionally be issued.

WHAT CAN I DO AFTER Oreana?

Through Oreana neonatal screening, you can benefit the affected infant’s health as well as the whole family. In case of a positive result, you can:

  • Start proactive treatment as soon as possible, to halt the natural progression of the disease

  • Look for the most applicable therapy

  • Refer the affected infant to specialists

  • Recommend carrier screening to family members, depending on the disease and the genetic status

  • Recommend genetic counselling to the family

HOW TO ADMINISTER Oreana NEONATAL SCREENING?

  • RECOMMEND Oreana TO THE INFANT’S PARENTS

  • COLLECT A CHEEK SWAB FROM THE INFANT

  • SEND THE SAMPLE TO NIPD Genetics

  • THE SAMPLE WILL BE ANALYZED IN OUR LABORATORY

  • RESULTS WILL BE SENT TO YOU WITHIN 2-3 WEEKS FROM SAMPLE RECEIPT TO THE LABORATORY

NIPD Genetics - Privacy Policy

General Statement

This Privacy Policy applies only to www.nipd.com and its subdomains (hereafter collectively referred to as “Sites") that link to this policy. NIPD Genetics Sites are owned by NIPD Genetics Public Company Ltd and are operated by NIPD Genetics Public Company Ltd and on occasion by a third-party that is responsible for the technical maintenance of the Sites.

If, you do not agree with this Privacy Policy, please do not access or use any of NIPD Genetics Sites.

NIPD Genetics values your interest in NIPD Genetics, its products and its services. NIPD Genetics takes the protection of your data seriously.

Personal data for purposes of this Privacy Policy, is any information by which you can be individually identified, including, but not limited to, your name, profession, address, e-mail address, and telephone number.

You may contact NIPD Genetics Public Company Ltd at
NIPD Genetics Public Company Ltd
Neas Engomis 31
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NIPD Genetics Data Protection Officer can be reached at dpo@nipd.com

This Privacy Policy applies only to the Sites as defined above and which are operated by NIPD Genetics. The NIPD Genetics Privacy Policy seeks to inform the users of its Sites of the following:

NIPD Genetics will not use or share your information with anyone, except as described in this Privacy Policy. This Privacy Policy does not apply to any information we might collect by other digital and offline means and or from other digital and offline sources. The use of information collected through our Sites shall be limited to the purposes under this Privacy Policy and our Terms of Use to customers.

This page informs you of our policies regarding the collection, use, and disclosure of personal data when you use our Sites and the choices you have associated with that data.

We use your data to provide and improve the Sites. By using the Sites, you agree to the collection and use of information in accordance with this policy. Unless otherwise defined in this Privacy Policy, terms used in this Privacy Policy have the same meanings as in our Terms and Conditions, accessible from www.nipd.com

Type of personal information NIPD Genetics may collect through its Sites

Information Collection And Use

We collect several different types of information for various purposes to provide and improve our Sites and services to you.

Personal Data

While using NIPD Genetics Sites, you may be asked to provide NIPD Genetics certain personally identifiable information that can be used to contact or identify you ("Personal Information"). Personal Information that might be used to identify you includes, but is not limited to:

If you send us a query via our Contact us form, your email address, the content and any follow up emails are retained indefinitely.

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We may also collect information how the Sites are accessed and used ("Usage Data"). This Usage Data may include information such as your computer's Internet Protocol address (e.g. IP address), browser type, browser version, the pages of our Sites that you visit, the time and date of your visit, the time spent on those pages, unique device identifiers and other diagnostic data.

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We use cookies and similar tracking technologies to track the activity on our Sites and hold certain information.

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Your information, including personal data, may be transferred to — and maintained on — computers located outside of your province, country or other governmental jurisdiction where the data protection laws may differ than those from your jurisdiction.

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Your consent to this Privacy Policy followed by your submission of such information represents your agreement to that transfer.

www.nipd.com will take all reasonable steps necessary to ensure that your data is treated securely and in accordance with this Privacy Policy and no transfer of your personal data will take place to an organization or a country unless there are adequate controls in place including the security of your data and other personal information.

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NIPD Genetics complies with the protection of personal data regulation and will not sale or trade your personal data.

NIPD Genetics may disclose your personal data in the good faith belief that such action is necessary to:

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The security of your data is important to us, but remember that no method of transmission over the Internet, or method of electronic storage is 100% secure. While we strive to use commercially acceptable means to protect your Personal Data, we cannot guarantee its absolute security.

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We may employ third party companies and individuals to facilitate, maintain or operate our Sites ("Service Providers"), to provide the SItes on our behalf, to perform service-related services or to assist us in analyzing how our Sites is used.

These third parties have access to your Personal Data only to perform these tasks on our behalf and are obligated not to disclose or use it for any other purpose.

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We may use third-party Service Providers to monitor and analyze the use of our Sites.

Google Analytics

Google Analytics is a web analytics service offered by Google that tracks and reports website traffic. Google uses the data collected to track and monitor the use of our Service. This data is shared with other Google services. Google may use the collected data to contextualize and personalize the ads of its own advertising network.

You can opt-out of having made your activity on the Service available to Google Analytics by installing the Google Analytics opt-out browser add-on. The add-on prevents the Google Analytics JavaScript (ga.js, analytics.js, and dc.js) from sharing information with Google Analytics about visits activity.

For more information on the privacy practices of Google, please visit the Google Privacy & Terms web page

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You have the right to review, update or delete any of your personal data by sending a request at NIPD Genetics Personal Data Officer pdo@nipd.com

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Our Sites may contain links to other sites that are not operated by us. If you click on a third-party link, you will be directed to that third party's site. We strongly advise you to review the Privacy Policy of every site you visit.

We have no control over and assume no responsibility for the content, privacy policies or practices of any third-party sites or services.

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Our Service does not address anyone under the age of 18 ("Children").

We do not knowingly collect personally identifiable information from anyone under the age of 18. If you are a parent or guardian and you are aware that your Children has provided us with Personal Data, please contact us. If we become aware that we have collected Personal Data from children without verification of parental consent, we take steps to remove that information from our servers.

Changes to This Privacy Policy

We may update our Privacy Policy from time to time. We will notify you of any changes by posting the new Privacy Policy on this page.

We will let you know via email and/or a prominent notice on our Service, prior to the change becoming effective and update the "effective date" at the top of this Privacy Policy.

You are advised to review this Privacy Policy periodically for any changes. Changes to this Privacy Policy are effective when they are posted on this page.

Contact Us

If you have any questions about this Privacy Policy, please contact pdo@nipd.com

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